Copper Histidinate: uses, dosing, side effects & brands
Copper Histidinate is a medicine sold in the U.S. under one brand, for menkes kinky hair syndrome. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Treats
- Menkes Kinky Hair Syndrome
- Available as
- Injectable
- Sold as
- Zycubo
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
How copper histidinate is dosed
From the FDA label for Zycubo (application NDA211241). Other copper histidinate products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Before initiating ZYCUBO, obtain baseline serum copper and ceruloplasmin levels, serum electrolytes, kidney and liver function, and complete blood count. ( 2.1 ) The recommended dosage of ZYCUBO in pediatric patients: Less than 1 year of age is 1.45 mg twice daily (8-12 hours between injections). ( 2.2 ) 1 year of age to less than 17 years of age is 1.45 mg once daily. ( 2.2 ) Monitor serum copper and ceruloplasmin levels, serum electrolytes, kidney and liver function, and complete blood count (CBC). ( 2.3 ) Reconstitute ZYCUBO and administer subcutaneously. ( 2.4 , 2.6 ) See Full Prescribing Information for additional preparation, storage, and administration instructions. ( 2.4 , 2.5 , 2.6 ) 2.1 Recommended Testing Before Initiating ZYCUBO Before initiating ZYCUBO, obtain baseline serum copper and ceruloplasmin levels, serum electrolytes, kidney and liver function, and complete blood count (CBC) [see Warnings and Precautions ( 5.1 )] . 2.2 Recommended Dosage and Administration The recommended dosage of ZYCUBO in pediatric patients: Less than 1 year of age is 1.45 mg administered subcutaneously twice daily (8-12 hours between injections). 1 year of age to less than 17 years of age is 1.45 mg administered subcutaneously once daily. 2.3 Dosage and Administration Modifications and Monitoring Monitor serum copper and ceruloplasmin levels, serum electrolytes, kidney and liver…
Copper Histidinate side effects
The following clinically significant adverse reactions are described elsewhere in the labeling: Copper Accumulation and Risk of Toxicity: Drug-Induced Kidney Injury, Liver Dysfunction, Hematological Abnormalities [see Warnings and Precautions ( 5.1 )] Most common adverse reactions (incidence ≥7%) were pneumonia, viral infection, respiratory failure, seizure, bacterial infection, hemorrhage, hypotension, vomiting, tachycardia, pyrexia, volume depletion, fracture, dyspnea, transaminases elevation, diarrhea, fungal infection, anemia, and local administration reaction. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sentynl Therapeutics, Inc. at 1-888-507-5206 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The pooled safety analysis from 2 open-label, single-arm clinical trials included a total of 129 ZYCUBO-treated patients with an age range from 0 to 48 months. Patients less than 1 year of age received ZYCUBO 1.45 mg twice daily, and patients 1 year of age and older received ZYCUBO 1.45 mg once daily. The median exposure duration was 24 months (range: 1 to 39 months) [see…
Who shouldn’t take copper histidinate
None. None ( 4 )
Every copper histidinate product we track (1)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
Only one: Zycubo.
What people report to the FDA about copper histidinate
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 1 reports naming copper histidinate, and the FDA flagged 100% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- urosepsis1 reports
Read these as a signal, not a rate. A report does not mean copper histidinate caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved July 25, 2026.
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Frequently asked questions
What is copper histidinate?
Zycubo (Copper Histidinate) is a medication used to treat Menkes Kinky Hair Syndrome.
Can you take copper histidinate with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run copper histidinate against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What forms does copper histidinate come in?
Across the brands we track, copper histidinate is currently marketed as injectable, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic copper histidinate?
We do not currently list a generic-labelled copper histidinate product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.
Cite this page
- APA
- pharmaranks. (2026, July 24). Copper Histidinate: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/copper-histidinate
- MLA
- “Copper Histidinate: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/copper-histidinate.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for copper histidinate on DailyMed (NIH) ↗.